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Clinical Trials/EUCTR2013-003817-16-ES
EUCTR2013-003817-16-ES
Active, not recruiting
Not Applicable

A phase III, randomized, controlled, single-blind,multicentre, parallel arm trial to assess theefficacy and safety of Pergoveris® (follitropin alfaand lutropin alfa) and GONAL-f® (follitropinalfa) for multifollicular development as part of anassisted reproductive technology treatment cyclein poor ovarian responders, as defined by theEuropean Society of Human Reproduction andEmbryology criteria - Pergoveris? in ART

Merck KGaA0 sites946 target enrollmentFebruary 27, 2014
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DrugsPergoveris 150 IU-75 IU Powder and solvent for solution for injectionGONAL-f 450 IU/0.75 ml (33 micrograms/0.75 ml) powder and solvent for solution for injection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Merck KGaA
Enrollment
946
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 27, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Merck KGaA

Eligibility Criteria

Inclusion Criteria

  • •The current trial will enroll poor ovarian responders according to specific criteria that are aligned with the POR criteria defined by ESHRE.
  • •At least 2 of the following 3 features must be present:
  • •\- Advanced maternal age (? 40 years)
  • •\- A previous POR (? 3 oocytes with a conventional stimulation protocol)
  • •\- An abnormal ovarian reserve test (ORT) (ie, anti\-mullerian hormone \[AMH] \< 0\.5 \- 1\.1 ng mL)
  • •Additional inclusion criteria are:
  • •1\. Female subjects, 18 to \< 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
  • •2\. Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
  • •3\. Absence of any medical condition in which pregnancy is contraindicated
  • •4\. Body mass index 18 to 30 kg/m2, inclusive

Exclusion Criteria

  • •1\. Two episodes of POR after maximal stimulation
  • •2\. History or presence of tumors of the hypothalamus or pituitary gland
  • •3\. History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst \> 25 mm on the day of randomization
  • •4\. Presence of endometriosis grade III ? IV, confirmed or suspected
  • •5\. Presence of uni\- or bilateral hydrosalpinx
  • •6\. Abnormal gynecological bleeding of undetermined origin
  • •7\. Contraindication to being pregnant and/or carrying a pregnancy to term
  • •8\. History or presence of ovarian, uterine or mammary cancer
  • •9\. Use of testicular or epididymal sperm

Outcomes

Primary Outcomes

Not specified

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A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteriainfertilitypoor ovarian responders10033283
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